MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RotaWire and wireClip Torquer; catheter, coronary, atherectomy

Model Number	3520
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire detachment and difficulty removal occurred, resulting in an unretrieved device fragment.The patient had diffused left anterior descending (lad) lesions with severe calcification.A rotawire 330cm gw(5pk) flop was selected for use.During coronary intervention, the rotational atherectomy guidewire was advanced into the distal end of the vessel via a microcatheter.When the guidewire was withdrawn into the main vessel, angiography revealed that the guidewire had fractured approximately 1 cm within the branch.The fractured segment could not be removed due to the small vessel size.The patient experienced unspecified complications.The rotational atherectomy procedure was completed normally and the patient was stable.It was further reported that the target lesion was 80% stenosed.The device was not removed from the patient, and there are no plans for a repeat procedure.There were no patient complications.
Event or Problem Description
It was reported that guidewire detachment and difficulty removal occurred, resulting in an unretrieved device fragment.The patient had diffused left anterior descending (lad) lesions with severe calcification.A rotawire 330cm gw(5pk) flop was selected for use.During coronary intervention, the rotational atherectomy guidewire was advanced into the distal end of the vessel via a microcatheter.When the guidewire was withdrawn into the main vessel, angiography revealed that the guidewire had fractured approximately 1 cm within the branch.The fractured segment could not be removed due to the small vessel size.The patient experienced unspecified complications.The rotational atherectomy procedure was completed normally and the patient was stable.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).With all the available information, boston scientific concludes: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: this investigation has been assigned an investigation conclusion code of adverse event related to patient condition, following a review of the reported event details, available information, and product record review.It is most likely the presence of reported anatomical factors, presented a constriction over the device and increased the friction when the device was advancing/withdrawing through the lesion reducing the mobility and generating the reported issues.Regarding the reported unretrieved device fragments, according to the event description, the guidewire detachment and removal difficulty may have been caused by a possible device malfunction that resulted in the reported issues.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

• Brand Name: RotaWire and wireClip Torquer
• Common Device Name: catheter, coronary, atherectomy
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 50070327
• Report Number: 2124215-2026-40586
• Device Sequence Number: 13382088
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: (01)08714729195566(17)270806(10)37149974
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0037149974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 08/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 154 LB